FDA.reportPublic FDA data

NDC 68788-9074-01 - Paroxetine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68788-9074
Requested NDC
68788-9074-01
Package NDCs from labels
68788-9074-3, 68788-9074-6, 68788-9074-9, 68788-9074-1, 68788-9074-8, 68788-9074-01
Manufacturer
Preferred Pharmaceuticals, Inc
Effective date
2026-08-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Paroxetine - Preferred Pharmaceuticals, IncPreferred Pharmaceuticals, Inc2026-08-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-9074-1Paroxetine100 in 1 BOTTLE, DISPENSINGTABLET, FILM COATED10011
68788-9074-3Paroxetine30 in 1 BOTTLE, DISPENSINGTABLET, FILM COATED3011
68788-9074-6Paroxetine60 in 1 BOTTLE, DISPENSINGTABLET, FILM COATED6011
68788-9074-8Paroxetine120 in 1 BOTTLE, DISPENSINGTABLET, FILM COATED12011
68788-9074-9Paroxetine90 in 1 BOTTLE, DISPENSINGTABLET, FILM COATED9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9074PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]10Current NDC, Legacy NDC, 5 package rows20240730_605c1d23-c97c-4ea4-92d0-fed351de9d2e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-9074-3EA - Each68788-9074f602ca7f-255b-4949-bed5-072b78b9537412022-07-06
68788-9074-6EA - Each68788-90741be643a4-597c-497f-9c02-46702556d51312019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PAROXETINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENT3I3T11UD2SPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]2
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 111 · 2,202 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
ParoxetinePAROXETINEPreferred Pharmaceuticals Inc.7d558598-6905-46da-8f34-668456c684112026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077584
rxcui: 1738511
unii: X2ELS050D8
ParoxetinePAROXETINEPreferred Pharmaceuticals Inc.ee38b589-e646-4203-bea5-cc3744fe17c32026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077584
rxcui: 1738503
unii: X2ELS050D8
ParoxetinePAROXETINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc605c1d23-c97c-4ea4-92d0-fed351de9d2e2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077584
ndc (package): 68788-0797-8
ndc (package): 68788-9074-3
ndc (package): 68788-0797-1
ndc (package): 68788-9074-8
ndc (package): 68788-9074-1
ndc (package): 68788-9074-6
ndc (package): 68788-0797-9
ndc (package): 68788-9074-9
ndc (package): 68788-0797-3
ndc (package): 68788-0797-6
ndc (product): 68788-0797
ndc (product): 68788-9074
ndc11 (package): 68788907401
rxcui: 1738495
rxcui: 1738483
spl id: 52cc8811-3e6d-4078-80d6-18cb06073b21
spl set id: 605c1d23-c97c-4ea4-92d0-fed351de9d2e
unii: X2ELS050D8
ParoxetinePAROXETINEREMEDYREPACK INC.05ec70fd-4c65-495f-ba12-e8433a10b6552026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077584
rxcui: 1738495
unii: X2ELS050D8
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
ParoxetinePAROXETINEREMEDYREPACK INC.c002508e-f96c-413b-b232-5d55fceeffe02026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077584
rxcui: 1738483
unii: X2ELS050D8
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEREMEDYREPACK INC.88b4c469-19b3-44b9-a378-c7c3f4f436db2026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1738503
unii: X2ELS050D8
ParoxetinePAROXETINEREMEDYREPACK INC.f52ca1fc-fbf7-4b2b-9e74-975c310b8ce62026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1738483
unii: X2ELS050D8
ParoxetinePAROXETINEREMEDYREPACK INC.679e4b9b-0f7b-450a-aca7-1b448cccbeed2026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077584
rxcui: 1738503
unii: X2ELS050D8
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.